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Home > "A" Clinical Trials Conditions > A Study of MKC-442 in Combination with Other Anti-HIV Drugs  A Study of MKC-442 in Combination with Other Anti-HIV Drugs
A Study of MKC-442 in Combination with Other Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Triangle Pharmaceuticals ,
Synopsis: The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.
Details: Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T), didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-442. Patient must have: - HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method within 30 days of entry. - A failed protease inhibitor-containing regimen. - Negative serum beta human chorionic gonadotropin test within 30 days of entry. Prior Medication: Allowed: - Prior nucleoside reverse transcriptase and protease inhibitors. - Cytotoxic chemotherapy more than 30 days prior to entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort. - Inadequately controlled seizure disorder. - Known intolerance to stavudine, didanosine, and/or hydroxyurea. - Acute and clinically significant medical event within 30 days of screening. - Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of laboratory values given. Concurrent Treatment: Excluded: Any experimental antiretroviral therapy or immunomodulators directed against HIV-1, e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitor therapy. Prior Treatment: Excluded: - Radiation therapy within 30 days of entry except to a local lesion. - Transfusion of blood or blood products within 21 days of screening. - Cytotoxic therapy within 3 months of study entry. Risk Behavior: Excluded: Active substance abuse that may interfere with compliance or protocol evaluations.
Total Enrollment:
Location and Contact Information:
Dr Robert Wallace
St. Petersburg, Florida, 33713
United States
Additional Information:
Study ID Numbers: 292C; MKC-305
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002412
Other Hiv Infections Studies:
1. Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
2. Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC
3. A Study of Azidothymidine in HIV-Infected Children
4. A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts
5. A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
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A Study of MKC-442 in Combination with Other Anti-HIV Drugs
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